Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol

Author:

Turgeon Alexis FORCID,Fergusson Dean AORCID,Clayton Lucy,Patton Marie-Pier,Zarychanski Ryan,English Shane,Docherty Annemarie,Walsh Timothy,Griesdale Donald,Kramer Andreas H,Scales Damon,Burns Karen E. A.,Boyd John Gordon,Marshall John C,Kutsogiannis Demetrios J,Ball Ian,Hébert Paul C,Lamontagne Francois,Costerousse Olivier,St-Onge Maude,Lessard Bonaventure Paule,Moore Lynne,Neveu Xavier,Rigamonti Andrea,Khwaja Kosar,Green Robert S,Laroche Vincent,Fox-Robichaud AlisonORCID,Lauzier FrancoisORCID

Abstract

IntroductionTraumatic brain injury (TBI) is the leading cause of mortality and long-term disability in young adults. Despite the high prevalence of anaemia and red blood cell transfusion in patients with TBI, the optimal haemoglobin (Hb) transfusion threshold is unknown. We undertook a randomised trial to evaluate whether a liberal transfusion strategy improves clinical outcomes compared with a restrictive strategy.Methods and analysisHEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatiON is an international pragmatic randomised open label blinded-endpoint clinical trial. We will include 742 adult patients admitted to an intensive care unit (ICU) with an acute moderate or severe blunt TBI (Glasgow Coma Scale ≤12) and a Hb level ≤100 g/L. Patients are randomly allocated using a 1:1 ratio, stratified by site, to a liberal (triggered by Hb ≤100 g/L) or a restrictive (triggered by Hb ≤70 g/L) transfusion strategy applied from the time of randomisation to the decision to withdraw life-sustaining therapies, ICU discharge or death. Primary and secondary outcomes are assessed centrally by trained research personnel blinded to the intervention. The primary outcome is the Glasgow Outcome Scale extended at 6 months. Secondary outcomes include overall functional independence measure, overall quality of life (EuroQoL 5-Dimension 5-Level; EQ-5D-5L), TBI-specific quality of life (Quality of Life after Brain Injury; QOLIBRI), depression (Patient Health Questionnaire; PHQ-9) and mortality.Ethics and disseminationThis trial is approved by the CHU de Québec—Université Laval research ethics board (MP-20-2018-3706) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.Trial registration numberNCT03260478.

Funder

Institute of Health Services and Policy Research

Publisher

BMJ

Subject

General Medicine

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